11+ ISO 13485 Jobs in Pune | ISO 13485 Job openings in Pune

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

Key Responsibilities

• Lead end-to-end SAP PLM implementation projects, including design, configuration, and deployment.
• Provide expert-level guidance in Specification Management, Recipe Development, and PLM Labeling.
• Develop and enhance workflows and change management processes within the SAP PLM framework.
• Design and implement PLM integrations with third-party systems.
• Create and manage PLM master data, ensuring accuracy and consistency across the system.
• Participate in solutioning for multiple enhancements in the areas of Specification, Recipe, and Labeling.
• Conduct PLM data modeling, data migration, and support S/4HANA upgrade projects.
• Oversee the configuration and system setup for PLM modules.
• Establish and manage release processes, ensuring timely delivery of system updates.
• Handle incidents and support requests related to SAP PLM functionalities.
• Collaborate with cross-functional teams to ensure alignment with business requirements.

Qualifications and Experience

• 6-10+ years of experience in SAP PLM, with a proven track record in implementation projects.
• Expertise in Specification Management, Recipe Development, PLM Labeling, and Workflow Management.
• Experience in Change Management processes within SAP PLM.
• Proficiency in integrating SAP PLM with third-party systems.
• Hands-on experience with PLM data modeling and data migration activities.
• Familiarity with S/4HANA upgrades and migrations is highly desirable.
• Strong background in FMCG and/or life sciences industries is a plus.
• Ability to manage PLM master data creation and configuration processes.
• Experience in system setup, release management, and incident handling for SAP PLM.

Key Skills:

• Strong problem-solving and analytical skills.
• Excellent communication and stakeholder management abilities.
• Ability to lead and mentor technical and functional teams.
• Proficiency in SAP Fiori and modern user interfaces for PLM modules.
• In-depth knowledge of regulatory requirements in FMCG and life sciences industries.

Frontend developer with knowledge and experience in ReactJS, Jquery, Html, CSS.

Good Analytical thinking

Understand client requirements 

Good Know ledge of testing APIs for integration.

Experience in Redux and React

Hello!

We at FindingPi Pvt. Ltd. are looking for an efficient Project Manager to contribute to and support the planning and execution of projects. The Project Manager's responsibilities include monitoring project progress, following up with stakeholders on the completion or delay of project phases, scheduling meetings, and maintaining project documents and reports.

Roles & Responsibilities:

• Coordinate internal resources and third parties/vendors for the flawless execution of multiple projects.

• Delegate project tasks based on junior staff members' individual strengths, skill sets, and experience levels.

• Track project performance, specifically to analyze the successful completion of short and long-term goals.

• Assist in the definition of project scope and objectives, involving all relevant internal stakeholders and ensuring technical feasibility.

• Ensure that all projects are delivered on time, within the scope, and within budget.

• Create and manage Agile artefacts like User Stories, Tasks, Issues, etc.

• Ensure resource availability and allocation.

• Measure performance using appropriate project management tools and techniques

• Report and escalate issues to management as needed.

• Establish and maintain relationships with third parties/vendors. Manage the relationship with the client and relevant stakeholders.

• Perform risk management to minimize potential risks.

• Create and maintain project documentation as per the process. Develop spreadsheets, diagrams, and process maps to document needs

• Use and continually develop leadership skills and perform other related duties as assigned.

Requirements:

• Bachelor's Degree in the appropriate field of study or equivalent work experience

• 2+ years of working experience in project management

• Hands-on experience with project management software tools like JIRA.

• Excellent client-facing and internal communication skills

• Excellent written and verbal communication skills

• Solid organizational skills including attention to detail and multitasking skills

• Strong working knowledge of Microsoft Office

• Project Management Professional (PMP) / PRINCE II certification is a plus
•  

Job Location: Shivaji Nagar, Pune (WFO)

Description

Zycus is looking for a Meanstack/Mernstack Developer, who is motivated to combine the art of design with the art of programming. Responsibilities include implementing visual elements and their behavior with user interactions.. You will also be playing an active role on front end as well as backend development, and defining how the application looks and functions. We are looking for candidates with strong experience in MongoDB, Express.js, Angular, Node.js, Javascript, HTML, CSS, Jquery, Ajax. If you are a Mean Stack or full stack developer with a strong technical experience, then you could be the best fit for the role!

Roles & Responsibilities

· Creating Apps by working on all layers of architecture Understanding the flow of code and how it interacts with different components.

· Creating technical design documents by understanding requirements, and product objectives.

· Writing effective Unit tests

· Good analytical skills and innovative mind.

· Source code management.

· Excellent communication skills.

Requirements

· Total experience of 5 - 8 years

· Experience on Mean Stack/Mernstack (MongoDB, Express.js, Angular, Node.js)

· Strong understanding of JavaScript, object-oriented JS, its quirks, and workarounds·

· Strong hands on experience in JavaScript· Strong proficiency with JavaScript or CoffeeScript depending on your technology stack.·

· Good understanding of server-side CSS preprocessors such as Stylus, Less·

· Basic understanding of web markup, including HTML5 and CSS3· Good understanding of asynchronous request handling, partial page updates, JQuery, and AJAX·

· Proficient understanding of cross-browser compatibility issues and ways to work around such issues· Familiarity with JavaScript module loaders, such as Require.js and AMD·

· Proficient understanding of code versioning tools, such as SVN· Good understanding of browser rendering behaviour and performance

· Key Programming Skills: MEAN stack, full stack, Angular, Java, HTML/CSS, Javascript, Bootstrap.

· Experience working with Rest based APIs

Five Reasons Why You Should Join Zycus

1. Cloud Product Company: We are a Cloud SaaS Company and our products are created by using the latest technologies like ML and AI. Our UI is in Angular JS and we are developing our mobile apps using React.

2. A Market Leader: Zycus is recognized by Gartner (world’s leading market research analyst) as a Leader in Procurement Software Suites.

3. Move between Roles: We believe that change leads to growth and therefore we allow our employees to shift careers and move to different roles and functions within the organization

4. Get a Global Exposure: You get to work and deal with our global customers.

5. Create an Impact: Zycus gives you the environment to create an impact on the product and transform your ideas into reality. Even our junior engineers get the opportunity to work on different product features.

• Minimum 1 years of relevant experience, in PySpark (mandatory)
• Hands on experience in development, test, deploy, maintain and improving data integration pipeline in AWS cloud environment is added plus 
• Ability to play lead role and independently manage 3-5 member of Pyspark development team 
• EMR ,Python and PYspark mandate.
• Knowledge and awareness working with AWS Cloud technologies like Apache Spark, , Glue, Kafka, Kinesis, and Lambda in S3, Redshift, RDS

Our client is looking for a Senior/Lead Full Stack .Net Developer for their headquarter office which is located in San Francisco, California. Looking for top-notch developers who are passionate and well-versed with modern technologies like .Net Core, MVC, SQL, and JS frameworks.

This position gives you an opportunity to lead exciting projects, work directly with teams in the US and with super smart people that you can learn from, and contribute to their knowledge.

Requirement:

• 7-15 years of experience in software development.
• Hands-on design and coding are required.
• Expertise in React.JS.
• Good knowledge of database concepts and Microsoft SQL Server.
• Highly proficient in modern JavaScript, HTML, CSS, ReactJs, and in one or more libraries for state management (e.g. Redux)
• Solid foundation in computer science, with strong competencies in data structures, design patterns, concurrency, algorithms, and software design
• Research and evaluate new software, frameworks, and techniques to provide recommendations to the division.
• Design and develop robust and scalable software components.
• Strong analytical and troubleshooting skills.
• Bachelor's degree in Computer Science or a technical field.

Perks & Benefits:

• Friendly, talented, collaborative, and entrepreneurial team
• Competitive and comprehensive benefits and perks
• Generous holiday and PTO policies
• Training and development opportunities and allowance
• Fun and inclusive digital, and (in the future) in-person events
• Employee groups - DEI committee, fun committee, wellness group, and more
• Flexible remote work

About company

The company is the industry-leading collection of online destinations (including Astrology.com, Horoscope.com, Keen, and PsychicCenter) providing spiritual guidance on love, relationships, career, health, and life overall. They are passionate about connecting people with the world's best advisors (including psychics, tarot card readers, life coaches, and more) and content to empower everyone to live happier lives.

A team of over 100 employees is powered by their diverse perspectives and company core values:

• They are humble. They believe the best result is achieved by leveraging others perspectives
• They think like owners. They make decisions that optimize for the greater good of the organization
• They challenge limiting beliefs. They are at their best when they identify and shatter the status quo expectations.

The company is an equal opportunity workplace and is an affirmative action employer. They are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.